• FDA Strategy, Submission Pathway for Class 3 medical device
    • Cross-functional & Clinical leadership (Phases 1-4)
    • Medical Affairs Global Communications & OCM
    • Regulatory, Labeling & Submissions
    • PMO & PPM for R&D
    • Business & Enterprise Architecture & Information Management
    • Research & Development, Biologics, Hemophilia
    • Clinical Leadership, Oncology
    • Process Improvement, Sales Operations
    • Commercialization, Injectable/Combo Device
    • SAP, Sales & Distribution
    • R&D, Pharma, Biosimilar Regulatory Filing
    • New Biologic Product
    • Study Physician, Immuno-Oncology